BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LORENZ STERNAL CLOSURE SYSTEM

    MDR report key: 5872720 · Received August 12, 2016

    Report

    Report Number
    0001032347-2016-00404
    Event Type
    Injury
    Date Received
    August 12, 2016
    Date of Event
    April 11, 2016
    Report Date
    July 13, 2016
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    PK011076
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. REPORT THREE OF FOUR FOR THE SAME EVENT, REFERENCE 1032347-2016-00402 THROUGH 1032347-2016-00405.

    Additional Manufacturer Narrative · 1

    ONE JL PLATE (73-2645) WAS ALSO RETURNED AND VISUALLY EVALUATED. THE PLATE SHOW SIGNS OF NORMAL USE. THE PLATES THREADS WERE NOT DIMENSIONALLY EVALUATED DUE TO THE PLATES USE. THE COMPLAINT THAT THE SCREWS BACKED OUT CANNOT BE VERIFIED. THE MOST LIKELY UNDERLYING CAUSE OF THIS COMPLAINT CANNOT BE DETERMINED. POTENTIAL CAUSES ARE THE LOCKING THREADS STRIPPED DURING INSERTION AND SCREW INSERTED OFF-AXIS. IT IS ALSO NOT KNOWN IF THE SCREW WAS FULLY SEATED INTO THE PLATE AS DESCRIBED IN THE SURGICAL PROCEDURE. IN THE ABSENCE OF POSTOPERATIVE IMAGES/X-RAYS OR ANY INFORMATION FROM THE SURGEON, IT CANNOT BE CONFIRMED IF THE SCREW WAS PLACED INTO THE STERNAL BONE PER THE IFU. BECAUSE OF THESE REASONS, THE ROOT CAUSE IN THIS CASE CANNOT BE DETERMINED. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. SUPPLEMENTAL REPORT THREE OF FOUR FOR THE SAME EVENT, REFERENCE 1032347-2016-00402-2 THROUGH 1032347-2016-00405-2.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION. SUPPLEMENTAL REPORT THREE OF FOUR FOR THE SAME EVENT, REFERENCE 1032347-2016-00402-1 THROUGH 1032347-2016-00405-1.

    Description of Event or Problem · 1

    IT WAS REPORTED FOUR DAYS AFTER THE OPERATION IT WAS IDENTIFIED THAT FOUR SCREWS HAD LOOSENED/BACKED OUT FROM THE LOWER PART OF THE BREAST BONE. ONE WEEK LATER, A REVISION WAS CONDUCTED. DURING THE OPERATION, THE SURGEON IDENTIFIED THE SCREWS ON THE CENTER OF THE BREAST BONE ALMOST "DROPPED OFF" AND SOME OF THE SCREWS WERE BENT.

    Description of Event or Problem · 1

    THE CUSTOMER RESPONDED TO THE REQUEST FOR CLARIFICATION TO WHAT WAS MEANT BY THE SCREWS DROPPED OFF FROM THE STERNUM: THEY RESPONDED THE SCREWS BACKED OUT OF THE PLATE AND THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525170 LORENZ STERNAL CLOSURE SYSTEM PLATE 8 HOLE JL HRS BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R